KEVZARA EFFICACY

COMBINATION THERAPY


demonstrated rapid, sustained, consistent clinical response

RELEVANT TRIALS: MOBILITY, TARGET

Pivotal Trial Study Designs

ACR20 clinical response was observed in MTX-IR and TNF-IR patients as early as 2 weeks in MOBILITY and as quickly as 4 weeks in TARGET, respectively, after the first dose.1

ACR responses at week 242,3
ACR20 MOBILITY (MTX-IR) responses to treatment with KEVZARA® (sarilumab) after 24 weeks
ACR responseS at week 242,4
ACR20 TARGET (TNF-IR) responses to treatment with KEVZARA® (sarilumab) after 24 weeks
  • *P<0.0001; P<0.01.
  • DMARD(s) in TARGET and MOBILITY include MTX, sulfasalazine, leflunomide, and/or hydroxychloroquine.
KEVZARA provided patients with uncontrolled RA
fast, lasting clinical improvement1
ACR20 response sustained through week 521,2
ACR20 MOBILITY (MTX-IR) responses to treatment with KEVZARA® (sarilumab) through 52 weeks
ACR20 response sustained through week 241,2
ACR20 TARGET (TNF-IR) responses to treatment with KEVZARA® (sarilumab) through 24 weeks
  • §P<0.0001, P value is for descriptive purposes only and is not adjusted for multiplicity.
  • ||P<0.0001.
  • MTX-IR=methotrexate inadequate response; TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; ACR20=American College of Rheumatology 20% improvement criteria; MTX=methotrexate; q2w=once every 2 weeks; DMARDs=disease-modifying antirheumatic drugs.

Significant improvements in
HAQ-DI

∆HAQ-DI: MOBILITY ITT Population1,2
Improvements in HAQ-DI MOBILITY (MTX-IR) at week 16 with KEVZARA® (sarilumab)
∆HAQ-DI: TARGET ITT Population1,2
Improvements in HAQ-DI TARGET (TNF-IF) at week 12 with KEVZARA® (sarilumab)

OF MTX-IR PATIENTS MAINTAINED CLINICALLY MEANINGFUL IMPROVEMENT IN PHYSICAL FUNCTION THROUGH WEEK 52 WITH KEVZARA 200 mg + MTX3*
Week 16: KEVZARA 200 mg + MTX: 57% (229/399) vs placebo + MTX: 42% (169/398);
Week 52: KEVZARA 200 mg + MTX: 48% (190/399) vs placebo + MTX: 26% (104/398)

  • *Minimal clinically important difference. HAQ-DI change from baseline ≥0.3 units.
  • HAQ-DI=Health Assessment Questionnaire-Disability Index; MTX-IR=methotrexate inadequate response; TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; ITT=intent to treat; MTX=methotrexate; q2w=once every 2 weeks; DMARDs=disease-modifying antirheumatic drugs.

INHIBITION OF RADIOGRAPHIC PROGRESSION

56% OF MTX-IR PATIENTS HAD NO RADIOGRAPHIC PROGRESSION WITH KEVZARA AT 52 WEEKS vs 39% OF PATIENTS TREATED WITH PLACEBO2*

MEAN CHANGE IN mTSS
AT WEEK 522,3
Studies looking at the effects of KEVZARA® (sarilumab) inhibition of joint damage through week 52
Participants saw 91% greater inhibition of joint damage progression with KEVZARA 200mg + MTX vs placebo + MTX2

greater inhibition of joint damage progression
with KEVZARA 200 mg + MTX vs placebo + MTX2

  • *Defined as mean change from baseline in total Sharp score of ≤0.
  • Based on post hoc comparisons of mean change in mTSS per treatment group. Week 52 analysis employs linear extrapolation method to impute missing or post rescue data.2
  • MTX-IR=methotrexate inadequate response; mTSS=modified total Sharp score; MTX=methotrexate.

References:

  • Data on file, Sanofi/Regeneron. Integrated summary. October 25, 2019.
  • KEVZARA [prescribing information]. Bridgewater, NJ: Sanofi/Regeneron Pharmaceuticals, Inc.
  • Genovese MC, Fleischmann R, Kivitz AJ, et al. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a phase III study. Arthritis Rheumatol. 2015;67(6):1424-1437.
  • Fleischmann R, Genovese M, Lin Y, et al. Long-term safety of sarilumab in rheumatoid arthritis: an integrated analysis with up to 7 years’ follow-up. Rheumatology (Oxford). 2019. doi:10.1093/rheumatology/kez265. [Epub ahead of print].